Complaint Investigator (Quality)

Agilent Technologies; Bayan Lepas; Remote; MYR 60,000 - 80,000; Full time

Job summary

A leading global science company in Penang seeks a Complaint Investigator to ensure product quality and safety in medical devices. The role involves reviewing service records, documenting findings, and collaborating with various teams to address quality issues. Ideal candidates have a Bachelor’s degree in a related field and relevant experience in quality systems. This position allows for primarily remote work with occasional onsite visits.

Qualifications

• 3+ years of related experience in quality systems for medical devices.
• Experience in product investigations and medical device post-market activities.
• Familiarity with ISO 13485 and 21 CFR quality management system requirements.

Responsibilities

• Review service records for medical device complaints.
• Document findings including reportability assessment and root cause.
• Collaborate with cross-functional teams to address product safety issues.

Skills

Analytical skills

Problem-solving

Written communication in English

Verbal communication in English

Organizational skills

Attention to detail

Education

Bachelor's Degree in Biological Sciences or related field

Tools

SAP

Microsoft Office Products

Job description

Overview

This position is based in Penang / Northern Region of West Malaysia.

Agilent is dedicated to fostering discoveries that enhance the quality of life. We supply life science, diagnostic, and applied market laboratories worldwide with instruments, services, consumables, applications, and expertise. We aim to empower customers to find the answers and insights they need to improve the world around us. For more information, visit www.agilent.com.

Operating within the Product Quality & Incident Management organization, supporting Global Quality and Regulatory Affairs (GQRA), the Complaint Investigator will join the Complaint Management Center (CMC) team.

We are looking for a seasoned medical device/IVD professional who is eager to work in a dynamic and progressive environment. This role is crucial for ensuring the quality of our products and identifying early signs of potential issues. The Complaint Investigator will be hands-on, involved in the initial evaluation, investigation, processing, and closing of complaints, as well as assessing reportability to regulatory authorities, contributing to metrics, and ensuring timely complaint processing. You will collaborate closely with Agilent\'s Quality and Regulatory teams, Field Support Teams, Product Support, Research & Development, and manufacturing organizations to ensure thorough investigations.

Join our team of regulatory compliance professionals who are at the forefront of investigating global product performance, ensuring Agilent\'s products are safe and effective for those being diagnosed.

Responsibilities

• Review service records to identify product issues related to medical device/IVD quality complaints.
• Document comprehensive and accurate findings for each complaint investigation, including reportability assessment, root cause, conclusions, and corrective actions in compliance with regulatory requirements.
• Communicate and escalate investigation results and facilitate the decision-making process for failure investigations.
• Collaborate with cross-functional teams, including R&D, Quality, Manufacturing, Support and Service, Logistics, Regulatory Affairs, and Medical Affairs, to address product safety and quality issues.
• Support quality system investigations, including nonconformances, corrective actions, and preventive actions.
• Update and maintain complaint investigation procedures to ensure alignment with current standards and best practices.
• Conduct and facilitate product and process training sessions to enhance team competency.
• Participate in the analysis, tracking, and trending of complaints data for Global Quality and Regulatory Affairs meetings on a weekly and monthly basis and drive quality improvements.
• Provide support for global and local audits and inspections, ensuring compliance with regulatory standards and organizational requirements.

Remote Work

This position primarily allows for remote work with an occasional on-site visit for audit support or staff meetings as necessary. Positions placed remotely may need to be available for meetings in the US Pacific and Central time zones.

Qualifications

• Bachelor\'s Degree in Biological Sciences or related field (e.g., Biomedical Engineering, Systems Engineering, Pharmacology, Chemistry) preferred.
• Minimum 3+ years of related experience in quality systems for medical devices, product investigations and/or medical device post-market product surveillance activities.
• Strong analytical and problem-solving skills, demonstrating excellent written and verbal communication abilities in English.
• Proficient in data analysis and workflow troubleshooting, including instrumentation, arrays, and biological materials.
• Proven ability to manage and prioritize workload, meet deadlines, and work effectively in a dynamic environment.
• Exceptional organizational skills and attention to detail.
• Experience with SAP is preferred. Proficiency in Microsoft Office Products (Word, Excel, PowerPoint, Teams) or equivalent software applications is preferred.
• Flexibility and a positive outlook toward handling new processes, technology, and general change.
• Familiarity with ISO 13485, 21 CFR 820, 21 CFR 803, and QSR quality management system requirements and IVD products, preferred.

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